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Clinical Characterization of Very and Extremely Preterm Infants Who Received Excess Erythrocyte Transfusions With Respect to HAS 2014 Recommendations

Clinical Characterization of Very and Extremely Preterm Infants Who Received Excess Erythrocyte Transfusions With Respect to HAS 2014 Recommendations

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06909487
Acronym
CGR EXCESS
Enrollment
201
Registered
2025-04-03
Start date
2025-03-25
Completion date
2025-05-31
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Erythrocyte Transfusion, Excess Transfusion, Very Preterm and Extremely Preterm Birth

Keywords

Very preterm and extremely preterm birth, Anemia, Erythrocyte transfusion, excess transfusion

Brief summary

Prematurity affects around 60,000 births a year in France. Extremely premature babies are particularly fragile and require multiple erythrocyte transfusions to maintain an effective hemoglobin level for metabolism and continued somatic and neurological development. Many known risk factors, such as multiple blood sampling for biological diagnosis, lead to a more rapid fall in hemoglobin concentration, reducing the amount of oxygen delivered in the tissues. In addition, red blood cell regeneration is very low in premature infants, while the half-life of red blood cells is shorter than in older children and adults. The result is severe anemia. Its main treatment is erythrocyte transfusion. It is associated with biological benefits, but has digestive, ophthalmological, pulmonary, metabolic and neurological side effects. To ensure a good benefit/risk ratio, a commission of the HAS issued recommendations in 2014 for erythrocyte transfusion in premature infants \< 32 weeks of amenorrhea in France. Yet many transfusions continue to be performed outside the HAS 2014 criteria. A retrospective monocentric study was carried out in order to understand this situation. Data from premature infants \< 31 weeks of amenorrhea (wks) born between July 2022 and July 2024 were collected via computerized hospitalization records (DxCare, Diane and Demserv software). Their transfusion status during the first twenty-eight days of life was analyzed. The HAS decision algorithm was used to identify excess transfusions and develop a patient classification.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No

Inclusion criteria

* age : ≤ 28 days of life * Premature newborn with term of birth \< 31 weeks hospitalized in intensive care or neonatology intensive care at CHU Amiens-Picardie (CHU-AP) between July 2022 and July 2024, whether born at CHU-AP maternity unit or transferred secondarily

Exclusion criteria

* Newborn with term of birth ≥ 31 weeks and \> 28 days of life

Design outcomes

Primary

MeasureTime frame
number preterm infants receiving excess transfusions1 month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026